Validation of Artificial Intelligence-Based Facial Paralysis Assessment in Patients With Bell's Palsy (AI-FACE)

Cairo University (CU)

Status: Begins enrollment this month

Conditions: Bell's Palsy; Facial Nerve Paralysis

Treatments: Other: AI-Based Facial Assessment; Other: Sunnybrook Facial Grading System (FGS)

Study type: Observational

Funder types: Other

Identifiers

NCT07573358

P.T.REC/012/006311

Details and patient eligibility

About

This observational study aims to assess the concurrent validity of an artificial intelligence (AI)-based facial paralysis assessment system in patients with unilateral Bell's palsy. Currently, clinical assessment relies on subjective scales like the Sunnybrook Facial Grading System, which can vary between different observers. This study will compare AI-generated composite asymmetry scores-derived from real-time computer vision analysis of facial landmarks-with scores from the Sunnybrook system. The goal is to determine if AI can provide a valid, objective method for monitoring facial nerve recovery.

Full description

Participants with unilateral Bell's palsy will be recruited for a single assessment session. The assessment involves two primary components:

Clinical Assessment: A qualified physical therapist will grade the patient's facial function using the Sunnybrook Facial Grading System, which evaluates resting symmetry, degree of voluntary movement, and synkinesis.

AI Assessment: A computer-vision-based system will utilize a standard camera to detect 468 facial landmarks in real-time. The system calculates a composite asymmetry score by comparing the movement amplitude and positioning of the affected side of the face against the healthy side during standardized facial expressions.

The study will utilize Spearman's rank correlation coefficient to analyze the relationship between the AI-derived scores and the Sunnybrook scores to establish concurrent validity. No personal images or videos will be stored; the AI performs real-time processing and immediate data deletion to ensure participant privacy.

Enrollment: 63 estimated patients

Sex: All

Ages: 25 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with unilateral Bell's palsy.
• Patients must be within one month of onset of Bell's palsy symptoms at the time of enrollment.
• Body mass index (BMI) less than 30 $kg/m^2$.
• Patients must be cooperative and able to follow simple verbal instructions during facial movement tasks.

Exclusion criteria

• Bilateral facial paralysis or recurrent Bell's palsy.
• Facial nerve palsy due to known secondary causes (e.g., trauma, neoplasm, infection, stroke, Ramsay Hunt syndrome, or otitis media).
• Facial deformities, scars, or burns that interfere with facial motion detection.
• Uncooperative or cognitively impaired individuals unable to follow instructions or maintain required facial postures.

Trial design

63 participants in 1 patient group

Patients with Unilateral Bell's Palsy

Description:

Sixty-three patients of both sexes, aged 25-40 years, with a body mass index (BMI) less than 30 $kg/m\^2$. Participants must be within one month of the onset of Bell's palsy symptoms and be able to follow verbal instructions during facial movement tasks.

Treatment:

Other: Sunnybrook Facial Grading System (FGS)

Other: AI-Based Facial Assessment